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All Early Infant Diagnosis

Early infant diagnosis establishes the presence of HIV infection in HIV-exposed infants and children younger than 18 months of age. An essential first step in caring for HIV-infected children is accurate and early diagnosis of HIV—early HIV testing, prompt return of results, and rapid initiation of treatment. Globally between 2002-2016 there was a 66% decline in new pediatric HIV infections; however, only ~50% of HIV-exposed infants received a test by two months of age in 2016 in 21 priority countries (UNAIDS, 2017). This collection of resources and tools helps you find what you need to scale up early infant diagnosis.

Catalyzing Expanded Access to Early Testing, Care, and Treatment for HIV-exposed Infants in Kenya

EGPAF / Unitaid, 2017.

Through the incorporation of point-of-care (POC) early infant diagnosis (EID) into the national diagnostic network in Kenya, EGPAF aims to increase the number of infants whose HIV status is known and the number of infants living with HIV who are initiated on treatment. This issue brief describes the targets to be reached by 2019. EGPAF worked with the Ministry of Health in order to strategically place POC platforms within the national diagnostic network and supported the enrollment of the first POC EID site in 2017 in Homabay County.

The Value of Confirmatory Testing in Early Infant HIV Diagnosis Programmes in South Africa: A Cost-Effectiveness Analysis

The specificity of nucleic acid amplification tests (NAATs) used for early infant diagnosis (EID) of HIV infection is <100%, leading some HIV-uninfected infants to be incorrectly identified as HIV-infected (false positive diagnoses). The World Health Organization recommends that infants undergo a second NAAT to confirm any positive test result, but implementation is limited. This study used a computer simulation model of pediatric HIV infection, diagnosis, and treatment to examine the clinical and economic outcomes of EID programs with and without confirmatory testing in South Africa. The authors conclude that confirmatory testing prevents inappropriate HIV diagnosis, is cost-saving, and should be adopted in all EID programs.

WHO Information Note: Novel Point-of-Care Tools for Early Infant Diagnosis of HIV

World Health Organization, 2017.

This July 2017 WHO information note highlights the significant progress that has been made in ensuring the quality of new point-of-care (POC) EID technologies. POC EID provides the opportunity to reduce test turnaround times, limit patient loss along the HIV testing cascade, reduce infant mortality, and allow for task shifting to lower cadres of health workers at decentralized facilities.

A summary of two IAS 2017 sessions: Integrating Diagnostic Services at Point-of-Care (POC) and Bringing the Test to the Patient: Results from the Early Routine Use of POC HIV Testing in Resource-Limited Settings as well as links to POC-related IAS 2017 abstracts.

Piloting Very Early Infant Diagnosis of HIV in Lesotho: Acceptability and Feasibility among Mothers, Health Workers, and Laboratory Personnel

Project SOAR, 2017.

This IAS 2017 poster describes a Project SOAR pilot of very early infant diagnosis (VEID) in an observational prospective cohort of HIV-positive pregnant women and their infants in 13 health facilities in Lesotho. Interviews with mothers, health workers, and laboratory personnel concluded that VEID was acceptable and feasible, as it gave mothers the opportunity to know their child’s HIV status at birth. Mothers did not report that testing of their infant at birth would make them less likely to return for testing of their infant at six weeks. However, the study highlighted challenges within the existing EID system that must be addressed for birth testing to be effective, including strategies to strengthen counseling on infant HIV testing, improve turnaround time, increase the number of facility-based deliveries, and improve client tracing procedures.

Point of Care HIV Diagnostics: Bringing Faster Results for Early and More Effective Treatment

Unitaid, CHAI, UNICEF, ASLM, 2017.

Unitaid, in partnership with ASLM, CHAI, and UNICEF, launched the Point of Care (POC) diagnostics project “Accelerating Access and Integration of Innovative POC Diagnostics for HIV in National Diagnostics Programmes.” This technical brief summarizes early results from the initial phases of the project that have demonstrated the potential of POC diagnostic technologies to accelerate access to testing, and earlier and more effective treatment.

This article reviews the progress and challenges with EID scale-up over the past decade, and examines new strategies to scale-up EID in light of the global 90-90-90 targets and UNAIDS' 2020 Fast-Track goals to increase antiretroviral therapy access to 90% of children identified with HIV and reduce new HIV infections among children to fewer than 20,000 per year.

Early Diagnosis of HIV Infection in Infants—One Caribbean and Six Sub-Saharan African Countries, 2011–2015

Using data collected from seven countries supported by PEPFAR, progress in the provision of HIV testing services for early infant diagnosis (EID) was assessed. Difficulties in specimen transport, long turnaround time, and limitations in supply chain management were among the most commonly reported challenges to accessing services for EID. Understanding the factors associated with delays in the pretest, test, and posttest phase could inform interventions to minimize turnaround time and improve follow-up and linkage to care. Strengthening specimen referral networks and supply chain management is necessary. Additionally, addressing the issues of integration between programs, mothers and children lost to follow-up, and the inability to reach children out of the health care system is needed to increase access to testing services for EID.

Clinical Impact and Cost-effectiveness of Diagnosing HIV Infection During Early Infancy in South Africa: Test Timing and Frequency

This study simulated four early infant diagnosis (EID) testing strategies for HIV-exposed infants in South Africa: no EID, testing once (at birth alone or at 6 weeks of age alone, and testing twice (at birth and 6 weeks of age). The study calculated incremental cost-effectiveness ratios, using discounted costs and life expectancies for all HIV-exposed (infected and uninfected) infants. The authors concluded EID at birth and 6 weeks improves outcomes and is cost-effective, compared with EID at 6 weeks alone—if scale-up costs are comparable, policymakers should add testing at birth after optimizing 6 weeks only strategies, alongside careful attention to retaining infants with negative results of tests at birth in care.

This commentary reviews advances in the field of HIV diagnosis in infants and describes how these advances may overcome barriers to access to testing and treatment. Innovations discussed include: point-of-care testing, use of SMS printers to connect the central laboratory and the health facility through a mobile phone network, expanding pediatric testing to other entry points where children access the health system, and testing HIV-exposed infants at birth.

In this AIDS 2016 presentation, WHO highlighted that EID coverage remains low in 21 Global Plan priority countries and shared key new recommendations for EID from the 2016 Consolidated Guidelines on the Use of Antiretroviral Drugs for Treating and Preventing HIV Infection, including that the addition of nucleic acid testing (NAT) at birth to existing EID testing approaches can be considered. WHO also recommended that NAT technologies developed and validated for use at or near point-of-care can be used for early infant HIV testing. To reduce delays, mHealth communication can be considered to transfer test results.

In this AIDS 2016 presentation, pooled data from an independent field evaluation in six countries conducted under the EID Consortium demonstrated that point-of-care EID devices perform well compared with conventional EID platforms. For specimens from HIV-exposed infants <18 months, the Alere Q HIV ½ Detect had a sensitivity of 99.07% and specificity of 99.94% and the Cepheid GeneXpert had a sensitivity of 96.88% and specificity of 99.92%.

This AIDS 2016 presentation describes a two-step process for point-of-care EID site identification in Lesotho through site mapping and capacity assessments concluding that selection of eligible POC sites is possible before product selection, products can then be selected to conform to the site profile.

This AIDS 2016 presentation describes Global Fund efforts to provide a range of credible, cost-effective, competitive options with more transparent pricing and contracting—accessible to all—and highlights the online Viral Load and EID Selection and Procurement Tool. A table with suppliers (July 2016) and their testing products and regulatory status is included.

A Proposed Framework for the Implementation of Early Infant Diagnosis Point-of-Care

This article describes progress made in follow-up of HIV-exposed infants since 2006, including remaining unmet laboratory and programmatic needs, and recommends strategies for improvement, especially those related to the implementation of point-of-care technology for early infant diagnosis.

This presentation provided a global update on the HIV epidemic in women and children and PMTCT, a primer on diagnosing HIV infection in infants, a summary of EID implementation, and an overview of birth testing considerations and controversies.

Consolidated Guidelines on the Use of Antiretroviral Drugs for Treating and Preventing HIV Infection: Recommendations for a Public Health Approach – 2nd Ed.

World Health Organization (WHO), (2016).

These guidelines provide guidance on the diagnosis of HIV infection, the use of antiretroviral (ARV) drugs for treating and preventing HIV infection and the care of people living with HIV. The guidelines present several new recommendations, including the recommendation to provide lifelong ART to all children, adolescents and adults, including all pregnant and breastfeeding women living with HIV, regardless of CD4 cell count.

Impact of Point-of-Care EID Testing into the National EID Program: Pilot Experiences from Malawi

Ministry of Health, Malawi, (2016).

This IAS 2016 presentation summarizes the POC EID testing pilot experiences in Malawi including site selection, preliminary findings—including device utilization, entry point deployment, patient impact, and acceptability, as well as operational challenges and recommendations for implementation of POC EID.

On the Fast-Track to an AIDS-Free Generation: The Incredible Journey of the Global Plan Towards the Elimination of New HIV Infections Among Children by 2015 and Keeping their Mothers Alive

Joint United Nations Programme on HIV/AIDS (UNAIDS), (2016).

This report summarizes the history and development of the Global Plan, its achievements in reaching ambitious goals, lessons learned, and directions for future progress to end new HIV infections among children.

Where Have All the Children Gone? High HIV Prevalence in Infants Attending Nutrition and Inpatient Entry Points

Central Public Health Laboratories, Uganda, (2016).

This presentation summarizes study results of HIV prevalence among infants at different entry points in health facilities in Uganda to understand how to allocate resources more efficiently to identify HIV-positive infants and link them to care and treatment.

Recalibrating the EID Cascade in Zimbabwe

Ministry of Health and Child Care Zimbabwe, (2015).

This ICASA 2015 presentation outlines a study in Zimbabwe to estimate the proportion of mother-baby pairs in Mashonaland East Province with documented uptake of EID within three months of birth, trace a randomly selected sample with no documented EID to determine whether they had HIV testing, and to establish the reasons for no EID.

What’s New in Infant Diagnosis

World Health Organization (WHO), (2015).

This WHO Fact Sheet highlights that in 2014, only 50% of all HIV-exposed infants were tested by the second month of age. Innovative approaches such as use of assays at the point-of care and adding virological testing at birth could speed up identification and ART initiation. Operational research to fully inform how to implement such innovations remains critical.

WHO Recommendations on the Diagnosis of HIV Infection in Infants and Children

World Health Organization (WHO), (2010).

This publication summarizes current knowledge on the methods of diagnosing HIV infection in infants and children and sets out recommendations for practice and policy. Recommendations are designed to improve clinical management of the HIV-exposed and -infected child, and improve programme efforts at early identification of HIV-exposed and infected children.

New! Impact of SMS/GPRS Printers in Reducing Time to Early Infant Diagnosis Compared With Routine Result Reporting: A Systematic Review and Meta-Analysis

Short message service (SMS) and general packet radio service (GPRS) printers allow test results to be transmitted immediately to health facilities on completion of early infant diagnosis (EID) testing in the laboratory. This systematic review and meta-analysis assessed the benefit of using SMS/GPRS printers to increase the efficiency of EID test result delivery compared to traditional courier paper-based results delivery.

New! Evaluating Turnaround Times for Early Infant Diagnosis Samples in Kenya from 2011-2014: A Retrospective Analysis of HITSystem Program Data

This retrospective analysis was conducted of HIV-exposed infants enrolled in 15 Kenyan hospital early infant diagnosis (EID) programs and in three laboratories using the HITSystem, an eHealth intervention that alerts staff when services are overdue or results are delayed. The authors assessed mean and median TAT from when a sample was: 1) obtained to when it was shipped to the laboratory; 2) shipped to when it was received at the laboratory, 3) received to when a result was posted; and 4) the total time from obtaining the sample to posting the result.

Conventional Early Infant Diagnosis in Lesotho from Specimen Collection to Results Usage to Manage Patients: Where are the Bottlenecks?

This retrospective study evaluated early infant diagnosis (EID) turnaround times in Lesotho and found that the major contributor to delays in turnaround time in the EID cascade was the time from receipt of specimen at the central laboratory to return of results to district laboratory, followed by the time for transfer of specimens from health center to district laboratory hub. Although HIV-exposed infants are brought to the clinic at an average of seven weeks of life to have their 6-weeks DNA-PCR EID test, it took over two months for caregivers to get the results back. The study concluded that the main bottleneck in the EID cascade in Lesotho was the central laboratory.

This webinar highlighted a study to evaluate the performance and benefit of point-of-care (POC) early infant diagnosis (EID) testing of HIV-exposed newborns at birth in Mozambique. The study aimed to determine the sensitivity, specificity, and predictive values of POC EID at birth compared with laboratory-based EID testing at birth, and the proportion of HIV-infected infants diagnosed by testing at birth and 4-6 weeks compared by testing only at 4–6 weeks.

This study, supported by the National Institutes of Health, PEPFAR/USAID, and UNICEF, describes the prevalence and outcomes of diagnostic challenges associated with HIV-1 PCR testing at birth in South Africa. While the majority of neonates with a positive HIV-1 PCR test at birth were confirmed to be HIV-1 infected, indeterminate results were associated with uncertainty and diagnostic delay. The authors conclude that the clinical requirements and social consequences of managing an infant with an indeterminate HIV-1 result make it critical that a timely and unequivocal diagnosis is established by the clinician and effectively communicated to the primary caregiver.

Report: Putting HIV and HCV to the Test: A Product Guide for Point-of-Care CD4 Tests and Laboratory-based and Point-of-Care HIV and HCV Viral Load Tests—3rd Ed

Médecins Sans Frontières (MSF), 2017.

This Médecins Sans Frontières (MSF) report is a guide for policymakers, treatment providers, and advocates interested in learning more about diagnostic and monitoring tests for HIV and hepatitis C virus (HCV), including both laboratory-based and point-of-care (POC) virological tests, and POC CD4 tests. HIV diagnostic companies were asked to provide information on the technical specifications of their products; pricing information; volume-based and tiered pricing; maintenance, training and warranty information; and contact information. Data was collected between April and June 2017 and includes technical specifications and pricing information for 22 diagnostic platforms comprising 48 test products.

National Guidelines in 55 Low and Middle-Income Countries for Early Infant Diagnosis and HIV Testing in Pregnant Women

Médecins Sans Frontières (MSF), 2017.

This Excel sheet provides supplementary material for the report, Putting HIV and HCV to the Test: A Product Guide for Point-of-Care (POC) CD4 Tests and Laboratory-based and POC HIV and HCV Viral Load Tests. It provides updated national guidelines on the use of infant diagnostic and HIV testing in pregnant women across 55 low- and middle-income countries, and the extent of implementation, sourced from the International Association of Providers of AIDS Care (IAPAC) database. It includes timing of early infant diagnosis for HIV-exposed infants within two months of birth and frequency of HIV testing in pregnant and breastfeeding women.

This article describes the implementation of a quality assurance program for laboratory-based and point-of-care HIV testing in Nigeria. With the support of the US Presidents Emergency Program for AIDS Relief (PEPFAR) program, Nigeria has upgraded its laboratory infrastructure for HIV diagnosis and monitoring including CD4, HIV serology, blood chemistry, hematology, HIV viral load, and early infant diagnosis testing for a total of 566 laboratories.

AIDS 2016—EID Consortium Technical Evaluation Results

In this AIDS 2016 presentation, pooled data from an independent field evaluation in six countries conducted under the EID Consortium demonstrated that point-of-care EID devices perform well compared with conventional EID platforms. For specimens from HIV-exposed infants <18 months, the Alere Q HIV ½ Detect had a sensitivity of 99.07% and specificity of 99.94% and the Cepheid GeneXpert had a sensitivity of 96.88% and specificity of 99.92%.

A data-driven laboratory harmonization and standardization approach is one way to create efficiencies and ensure optimal laboratory procurements. Following the 2008 ‘‘Maputo Declaration on Strengthening of Laboratory Systems’’—a call for government leadership in harmonizing tiered laboratory networks and standardizing testing services—several national ministries of health requested that the USG and in-country partners help implement the recommendations by facilitating laboratory harmonization and standardization workshops, with a primary focus on improving HIV laboratory service delivery. Between 2007 and 2015, harmonization and standardization workshops were held in eight African countries. This article reviews progress in the harmonization of laboratory systems in these eight countries.

WHO Manual for Organizing a National External Quality Assessment Programme for Health Laboratories and Other Testing Sites

WHO, (2016).

This manual describes some of the strategic, managerial, financial, technical and scientific aspects to be considered in establishing a national EQA programme for clinical laboratories and other testing services at all health care levels. The manual has been prepared by the World Health Organization (WHO) and partners to fill perceived gaps, and the scope is limited to EQA programmes that deliver proficiency testing. However, it is important to note that other EQA activities as well as internal quality control (process control) measures and other quality elements are an integral part of the quality laboratory management process as defined in ISO 15189:2013.

Xpert® MTB/RIF test Rollout and Implementation Plan

United Republic of Tanzania Ministry of Health and Social Welfare National Tuberculosis and Leprosy Programme, (2016).

The overall objective of this implementation plan is to define the strategy for implementation of the Xpert MTB/RIF test for rapid detection of TB and rifampicin (RIF) resistance in Tanzania, within the context of the National Tuberculosis and Leprosy Programme (NTLP) strategic plan and other national health guidelines. It is intended to serve as the main guiding document for national, regional and local programme managers, clinicians, coordinators, laboratory staff and other health workers; national and regional reference laboratories; local and international implementing partners; and donors involved in TB control.

HIV/AIDS Diagnostics Technology Landscape. 5th Edition

UNITAID, (2015).

This report reviews the current technology landscape for HIV diagnostics, including: (i) the algorithms and tests required in HIV care and treatment, both before and after ART initiation; (ii) the diagnostic platforms used and price points for testing; and (iii) the intended uses and appropriate settings for testing. With this information as background, the report then reviews the current technologies and diagnostic platforms in three key testing areas: CD4 and viral load (VL) testing for adults and children as well as EID, including EID run on VL platforms—all of which have traditionally been available only through centralized, high-infrastructure laboratory platforms, even for resource-limited settings. The report also describes the POC and near-POC platforms on the market and in the development pipeline, and considers the implications of the landscape, including what efficiencies might be achieved with respect to test algorithms, the cost of testing and decentralized service delivery.

Work Plan Template for Xpert MTB/RIF® Implementation and Scale-up

FIND, (2015).

The purpose of this document is to provide step-by-step instructions for completing an implementation and scale-up work plan for the Xpert MTB/RIF assay in your country. Completion of this template will yield a clear Xpert MTB/RIF work plan in accordance with national policy and plan requirements of your country. The work plan template is intended to guide the implementation of Xpert MTB/RIF testing in facilities providing clinical services.

Xpert MTB/RIF for People Living with HIV

WHO, (2014).

Xpert MTB/RIF is a fully-automated molecular test for the rapid and simultaneous detection of TB and rifampicin resistance that has the potential to revolutionize and transform TB care and control. It provides accurate results in less than two hours, has minimal biosafety and training requirements, and can be housed in non-conventional laboratories. This fact sheet summarizes WHO recommendations on Xpert MTB/RIF for PLHIV.

In October 2013, WHO issued updated Policy Guidance, providing revised recommendations on using of Xpert MTB/RIF to diagnose pulmonary TB, pediatric TB, extrapulmonary TB and rifampicin resistance. This edition of the Xpert MTB/RIF implementation manual replaces the first edition and takes into consideration the current body of evidence and operational experiences available, in the context of the updated policy recommendations. Expanding the scope of the use of Xpert MTB/RIF and its placement in diagnostic algorithms will have significant implications for operational implementation, and its use should be phased in within the context of national strategic plans for TB.

GeneXpert for TB Diagnosis: Planned and Purposeful Implementation

In December 2010, WHO endorsed Xpert for the rapid and accurate detection of TB, particularly among PLHIV and people suspected of having MDR-TB. Xpert can improve coordination between HIV and TB programs. This commentary outlines the cost and infrastructure requirements that are key challenges to Xpert implementation—while increased detection of MDR-TB through Xpert could increase the market for second-line anti-TB drugs and drive costs down.

The Excel-based spreadsheet tool, developed by USAID’s Health Finance and Governance (HFG) project, can be used to estimate the costs and human resource implications of scaling up HIV viral load monitoring and the use of viral load testing for early infant diagnosis (EID). Users can choose between different testing platforms, target populations, and supporting practices, and view outputs accordingly. A manual for application is also available.

Costs of HIV Viral Load and Early Infant Diagnosis Testing in Kenya

Health Finance & Governance (HFG) Project, 2017.

The USAID-funded Health Finance and Governance project (HFG) estimated unit costs of HIV viral load (VL) and early infant diagnosis (EID) testing in Kenya using a centralized laboratory network reporting on network utilization and outputs. It also estimates HIV VL and EID testing unit costs under a range of scenarios for two point-of-care (POC) diagnostic platforms being considered for deployment by the Ministry of Health (MOH) and partners. The report aims to help the MOH identify opportunities for cost savings, project resource needs as testing coverage expands, make informed decisions on the placement of POC technologies, and help achieve the 90-90-90 targets in Kenya.

Guidance for Procurement of In Vitro Diagnostics and Related Laboratory Items and Equipment

World Health Organization, 2017.

Poorly conducted procurement has a huge programmatic impact if stability of products and allowable shelf life for labile reagents are not foreseen as part of the procurement process. This WHO guidance aims to highlight the necessary factors to consider when procuring in vitro diagnostic medical devices (IVDs) and other laboratory items.

Briefing on Guidance for Procurement of In Vitro Diagnostics and Related Laboratory Items and Equipment

World Health Organization/USAID, 2017.

This presentation provides an overview of the 2017 WHO guidance for procurement of in vitro diagnostics (IVD) and related laboratory items and equipment. The overview includes roles and tips for users, procurers of IVDs, manufacturers, and national regulatory authorities.

A global procurement consortium has been formed to ensure uninterrupted provision of timely, high-quality early infant diagnosis and viral load test results in countries most in need. The consortium aims to catalyze demand for and uptake of POC technologies, and ensure sustainability of the market, by applying strategies such as: pooling test volumes across purchasers; sharing market intelligence; providing advanced procurement forecasts to manufacturers; agreeing on procurement principles and negotiation targets; jointly negotiating prices as well as service and maintenance terms; and coordinating the placement of orders. From October 2016 to July 2017, EGPAF monitored procurement indicators for POC EID devices and tests kits ordered for eight project countries: Cameroon, Côte d’Ivoire, Kenya, Lesotho, Mozambique, Rwanda, Swaziland, and Zimbabwe. This issue brief presents early results.

Point-of-Care EID: At What Price? Cost Considerations for Integrating POC EID into National Diagnostic Networks

EGPAF, Unitaid, 2017.

A consortium working across more than 13 African countries to improve the market for point-of-care early infant diagnosis (POC EID) technologies is collaborating to facilitate long-term price reductions in POC EID and increase access. These organizations are working with The Global Fund to leverage their volumes and harmonize contracts and ensure that The Global Fund grantees will be able to procure these technologies under the same negotiated terms through a most favored customer clause. This EGPAF issue brief provides a comparison between the advertised prices, total cost of ownership, and cost of goods analysis for POC EID cartridges as well as an analysis of the service and maintenance provisions of the two current quality-assurance systems for POC EID with suggested areas to improve access.

Economic Evaluation of Viral Load Testing and Early Infant Diagnosis in Rural Zimbabwe

Medecins Sans Frontieres, 2016.

This report assesses the cost of point-of-care (POC) GeneXpert technology for early infant diagnosis (EID) and viral load (VL) compared with conventional platforms in Zimbabwe. Three cost-analyses were conducted based on a retrospective study and simulations: (1) a simple cost analysis of the initial investment (capital cost); (2) a cost-efficiency analysis (cost/ output); and (3) a cost-effectiveness analysis (cost/ outcomes). This report outlines the results—cost of initial investment, running cost per test, simulated costs per test, and cost-effectiveness.

This AIDS 2016 presentation describes Global Fund efforts to provide a range of credible, cost-effective, competitive options with more transparent pricing and contracting—accessible to all—and highlights the online Viral Load and EID Selection and Procurement Tool. A table with suppliers (July 2016) and their testing products and regulatory status is included.

Availability and Use of HIV Monitoring and Early Infant Diagnosis Technologies in WHO Member States in 2011–2013: Analysis of Annual Surveys at the Facility Level

This article summarizes a survey of the availability and utilization of technologies for HIV treatment monitoring and EID in WHO Member States. The survey results suggest that major operational changes will need to be implemented, particularly in low- and middle-income countries, if the 90-90-90 targets are to be met.

Combined Global Demand Forecasts for Antiretroviral Medicines and HIV Diagnostics in Low- and Middle-Income Countries from 2015 to 2020

World Health Organization (WHO), (2016).

This report provides projections of the future demand for HIV diagnostics through 2020. These projections are intended to inform advocacy for the scaling up of access to diagnostics, so that the UNAIDS 90–90–90 target for HIV treatment access can be met. The projections will probably also be useful for producers, so that they can plan for adequate supply, and to procurement organizations in planning future funding and long-term purchase plans. Demand for early infant diagnosis tests is expected to rise from about 800,000 in 2014 to 1.8 million by 2020. The growth in demand will be driven by changes in the testing guidelines to include testing at birth, the introduction of point-of-care early infant diagnosis testing and additional partner funding. The full need under 90–90–90 would be even larger: about 2.8 million tests in 2020.

Global Access Initiative FAQ Document

Roche, (2016).

Roche launched the Global Access Program for HIV viral load testing which expands access to diagnostic testing. Through this program, Roche provides special access pricing on the COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Test version 2.0 for qualifying organizations in eligible countries. This document provides the pricing agreement for Roche machines and reagents.

List of Prequalified In Vitro Diagnostic Products

World Health Organization (WHO), (July 2016).

This document provides a list of WHO prequalified in-vitro diagnostic products updated in July 2016 including the year prequalified, type of assay, product name and codes, regulatory version, manufacturer/sites, and packaging.

UNITAID Investments to Innovate and Scale Up Access to HIV Diagnostics

Abbott Agreement Global Fund

Abbott, (2015).

In June 2015, Abbott was selected by the Global Fund as a panel supplier for HIV-1 Quantitative (VL) assay and HIV-1 Qualitative (EID) assay for an initial 3-year period. This document provides the pricing agreement for Abbott machines and reagents.

EID/VL POC Technology Performance Characteristics

90-90-90 Improving Access to Infant and Child HIV Diagnostics

UNAIDS, (2015).

This ICASA 2015 presentation emphasizes that with conventional EID, many test results are never received by the infant or caregiver and outlines POC HIV EID (and viral load) products— available and pipeline—and next stage POC technologies.

New! Interventions to Significantly Improve Service Uptake and Retention of HIV-Positive Pregnant Women and HIV-Exposed Infants along the PMTCT Continuum of Care: Systematic Review

This systematic review summarizes interventions that demonstrate statistically significant improvements in service uptake and retention of HIV-positive pregnant and breastfeeding women and their infants along the PMTCT cascade including uptake of early infant diagnostic testing and retention of mothers and infants.

New! Use of Mobile Phones and Text Messaging to Decrease the Turnaround Time for Early Infant HIV Diagnosis and Notification in Rural Zambia: An Observational Study

This study evaluated the use of mobile phones in Zambia to improve the process of early infant diagnosis. The feasibility of using mobile phones to notify mothers of the availability of test results either directly, or through their local rural health center, was assessed. In addition, the performance of a national short message service (SMS) reporting system to deliver test results from the central laboratory to the clinic was evaluated during the first two years of implementation.

Xpert HIV-1 Point-of-Care Test for Neonatal Diagnosis of HIV in the Birth Testing Programme of a Maternity Hospital: A Field Evaluation Study

This study described point-of-care testing (POCT) for HIV-exposed newborns and compares outcomes to universal laboratory-based testing (LABT) in South Africa. Mothers whose infants received POCT received their results in 96 percent of cases, while only 53 percent of mothers whose infants received LABT received their results. Infants diagnosed via POCT initiated treatment earlier than infants diagnosed via LABT (one day versus six days). The study concluded that POCT is accurate, increases the likelihood of the mother receiving the result, reduces waiting time, and decreases time to ART initiation.

Guinea Ministry of Health PMTCT Tools

Guinea Ministry of Health, 2016.

This package of Guinea Ministry of Health tools tracks women and exposed infants in PMTCT (PTME in French) under the National Program for Health Care and Prevention of STI / HIV / AIDS (PNPCSP in French). It includes the PMTCT Card, PMTCT Register, Exposed Infant Follow-up Card, Exposed Infant Register, and Monthly Report on PMTCT Activities.

This webinar provided a global update on the HIV epidemic in women and children and PMTCT, a primer on diagnosing HIV infection in infants, a summary of EID implementation, and an overview of birth testing considerations and controversies.

Algorithm for Early Infant Diagnosis

Guide to Implementation of Services for Early Diagnosis of HIV in Infants in Resource-Limited Settings: Book 1. Implementation Guide for Program Managers

CDC, (2009).

This implementation guide for program managers provides on overview of infant diagnosis for program managers. It covers the basics of setting up early infant diagnosis services, including choice of a test and an appropriate testing algorithm, clinical staff training needs, required laboratory infrastructure, and program evaluation.

Guide to Implementation of Services for Early Diagnosis of HIV in Infants in Resource-Limited Settings: Book 2: Training Curriculum for Clinical Staff

CDC, (2009).

This 5-module training curriculum on early infant diagnosis and infant follow-up is intended for midwives, nurses, doctors, and other healthcare staff. Following the training, staff members will be able to identify infants in need of testing, counsel caregivers before testing, and provide appropriate follow-up care for HIV-exposed and HIV-infected infants and young children. They will also learn how to collect, handle, and send dried blood spot (DBS) specimens for early infant diagnosis. The fifth module is an interactive group exercise that evaluates and reinforces skills gained from the training.

Children and AIDS

UNICEF

Children and AIDS is the online information portal and community for the HIV/AIDS programme of the United Nations Children's Fund (UNICEF). Through technical support, education, advocacy and a range of other efforts, UNICEF seeks to ensure that all babies, children, adolescents and their mothers can access life-saving HIV prevention, treatment, care and support.

Nigeria Early Infant Diagnosis Dashboard

Federal Ministry of Health Nigeria.

This Nigeria Federal Ministry of Health dashboard presents a summary of monthly early infant diagnosis trends including total infants tested, positivity rate, average age of testing, and reasons for PCR testing— presented for PMTCT and for rapid and infant testing.

Point-of-Care EIDs: Doing More, Faster: Preliminary Results from the Routine Use of POC EID in Six Sub-Saharan African Countries

EGPAF/Unitaid, 2017.

Since 2015, EGPAF, through funding and support from Unitaid, has been working to integrate point-of-care early infant diagnosis (POC EID) into the current EID system in nine high-prevalence countries: Cameroon, Côte d’Ivoire, Kenya, Lesotho, Mozambique, Rwanda, Swaziland, Zambia, and Zimbabwe. To understand the effect of POC EID, EGPAF is conducting a pre- and post-intervention evaluation. Pre-intervention, baseline data from infants tested using conventional, laboratory-based EID was collected prior to introducing POC technology. Baseline data was compared with POC EID data on key service delivery indicators. Pilot findings from six intervention countries are summarized in this EGPAF issue brief.

Point-of-Care Early Infant Diagnosis Data Dashboard

EGPAF/Unitaid, 2017.

Since 2015, EGPAF, through funding and support from Unitaid, has been working to integrate point-of-care early infant diagnosis (POC EID) into the current EID system in nine high-prevalence countries: Cameroon, Côte d’Ivoire, Kenya, Lesotho, Mozambique, Rwanda, Swaziland, Zambia, and Zimbabwe. To understand the effect of POC EID, EGPAF is conducting a pre- and post-intervention evaluation. Pre-intervention, baseline data from infants tested using conventional, laboratory-based EID was collected prior to introducing POC technology. Baseline data was compared with POC EID data on key service delivery indicators. Pilot findings from six intervention countries are summarized in this EGPAF interactive data visualization dashboard.

Confronting Challenges in Monitoring and Evaluation: Innovation in the Context of the Global Plan Towards the Elimination of New HIV Infections Among Children by 2015 and Keeping Their Mothers Alive

This article provides an overview of major achievements in M&E across Global Plan countries and highlights key challenges and innovative country-driven solutions using PMTCT program data, the authors also identify outstanding challenges and potential ways forward.

Guinea Ministry of Health PMTCT Tools

Guinea Ministry of Health, 2016.

This package of Guinea Ministry of Health tools tracks women and exposed infants in PMTCT (PTME in French) under the National Program for Health Care and Prevention of STI / HIV / AIDS (PNPCSP in French). It includes the PMTCT Card, PMTCT Register, Exposed Infant Follow-up Card, Exposed Infant Register, and Monthly Report on PMTCT Activities.

Tanzania Early Infant Diagnosis Dashboard

Tanzania Ministry of Health. 2011-2017

This Tanzania Ministry of Health online dashboard provides a snapshot of early infant diagnosis testing and outcomes trends—including total samples tested, rejected, total positives, and results by age—as well as regional statistics.

Kenya Early Infant Diagnosis Dashboard

MOH Kenya National AIDS & STI Control Programme (NASCOP 2017)

This MOH Kenya dashboard presents a summary of monthly early infant diagnosis testing trends including outcomes, with disaggregation by age, county, entry point, mother's prophylaxis, and infant prophylaxis, as well as HIV-exposed infant follow-up. Lab performance statistics for early infant diagnosis, including specimen rejection rate trends and turnaround times, are also presented.

Malawi Early Infant Diagnosis Dashboard

MOH Malawi 2010-2017

This MOH Malawi national online dashboard presents a summary of monthly EID tests, national lab test statistics, national lab turnaround times, EID results by age of testing, and reason for sample collection with filters by district and facility as well as a summary of EID sample submitting sites statistics by district.

The United States President’s Emergency Plan for AIDS Relief (PEPFAR), (2016).

This updated indicator reference guide emphasizes that PEPFAR's focus on impact in individuals and communities is the driving force for an effective framework that not only monitors outputs from the program but also key outcomes.

Monitoring & Evaluation Framework for Antiretroviral Treatment for Pregnant and Breastfeeding Women Living with HIV and Their Infants (IATT Option B/B+ M&E Framework)

The Interagency Task Team on the Prevention and Treatment of HIV Infection in Pregnant Women, Mothers and Children, (2015).

The IATT Option B/B+ M&E Framework contains 3 sections that provides guidance on: routine monitoring of lifelong care and treatment for pregnant and breastfeeding women living with HIV and their children which outlines the core indicators and key questions for all MNCH and HIV Care and Treatment facilities; enhanced monitoring to assess program quality and identify issues needing targeted intervention; and conducting evaluations and operational research to assess outcomes and effectiveness of national programs. Using this framework, stakeholders can review, adapt and update current monitoring systems and continuously evaluate programs, maximizing the potential impact of lifelong treatment programs to improve health outcomes and prevent HIV infections for women, their children and their families.

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The Strengthening High Impact Interventions for an AIDS-free Generation (AIDSFree) Project is a five-year cooperative agreement funded by the U.S. Agency for International Development under Cooperative Agreement AID-OAA-A-14-00046 with support from the U.S. President's Emergency Plan for AIDS Relief (PEPFAR). AIDSFree is implemented by JSI Research & Training Institute, Inc. with partners Abt Associates Inc., Elizabeth Glaser Pediatric AIDS Foundation, EnCompass LLC, IMA World Health, the International HIV/AIDS Alliance, Jhpiego Corporation, and PATH. The information provided on this website is not official U.S. Government information and does not represent the views or positions of USAID, PEPFAR, or the U.S. Government.